BR112017010445B8 - Processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estável - Google Patents
Processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estávelInfo
- Publication number
- BR112017010445B8 BR112017010445B8 BR112017010445A BR112017010445A BR112017010445B8 BR 112017010445 B8 BR112017010445 B8 BR 112017010445B8 BR 112017010445 A BR112017010445 A BR 112017010445A BR 112017010445 A BR112017010445 A BR 112017010445A BR 112017010445 B8 BR112017010445 B8 BR 112017010445B8
- Authority
- BR
- Brazil
- Prior art keywords
- compound
- diazabicyclo
- production process
- stable lyophilized
- crystals
- Prior art date
Links
- 239000013078 crystal Substances 0.000 title abstract 4
- NFDXQGNDWIPXQL-UHFFFAOYSA-N 1-cyclooctyldiazocane Chemical class C1CCCCCCC1N1NCCCCCC1 NFDXQGNDWIPXQL-UHFFFAOYSA-N 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 238000002360 preparation method Methods 0.000 title abstract 2
- 150000001875 compounds Chemical class 0.000 abstract 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 2
- 239000007864 aqueous solution Substances 0.000 abstract 2
- 238000004108 freeze drying Methods 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 229910017053 inorganic salt Inorganic materials 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000011780 sodium chloride Substances 0.000 abstract 1
- 238000003860 storage Methods 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D471/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
- C07D471/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains two hetero rings
- C07D471/08—Bridged systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2014246425 | 2014-12-05 | ||
| JP2014-246425 | 2014-12-05 | ||
| PCT/JP2015/084094 WO2016088863A1 (ja) | 2014-12-05 | 2015-12-04 | ジアザビシクロオクタン誘導体の結晶及び安定な凍結乾燥製剤の製造法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BR112017010445A2 BR112017010445A2 (pt) | 2017-12-26 |
| BR112017010445B1 BR112017010445B1 (pt) | 2024-01-30 |
| BR112017010445B8 true BR112017010445B8 (pt) | 2024-02-27 |
Family
ID=56091802
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112017010445A BR112017010445B8 (pt) | 2014-12-05 | 2015-12-04 | Processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estável |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US10294224B2 (de) |
| EP (1) | EP3228620B1 (de) |
| JP (1) | JP6779787B2 (de) |
| KR (1) | KR102555657B1 (de) |
| CN (1) | CN107001366B (de) |
| AR (1) | AR102915A1 (de) |
| AU (1) | AU2015355970B2 (de) |
| BR (1) | BR112017010445B8 (de) |
| CA (1) | CA2969192C (de) |
| ES (1) | ES2821826T3 (de) |
| IL (1) | IL252691B (de) |
| MX (1) | MX2017007191A (de) |
| MY (1) | MY190283A (de) |
| RU (1) | RU2732129C2 (de) |
| SG (1) | SG11201704576SA (de) |
| TW (1) | TWI691499B (de) |
| WO (1) | WO2016088863A1 (de) |
| ZA (1) | ZA201704063B (de) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG10201605368UA (en) | 2012-05-30 | 2016-08-30 | Meiji Seika Pharma Co Ltd | NOVEL β-LACTAMASE INHIBITOR AND PROCESS FOR PREPARING THE SAME |
| JP6617029B2 (ja) | 2013-10-08 | 2019-12-04 | Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 | ジアザビシクロオクタン誘導体の結晶とその製造法 |
| AU2015355970B2 (en) | 2014-12-05 | 2020-05-21 | Meiji Seika Pharma Co., Ltd. | Method for producing crystals of diazabicyclooctane derivative and stable lyophilized preparation |
| CN111447924A (zh) * | 2017-09-27 | 2020-07-24 | 费多拉制药公司 | 二氮杂二环辛烷衍生物的药物形式及其制备方法 |
| US10584123B2 (en) | 2017-09-27 | 2020-03-10 | Fedora Pharmaceuticals Inc. | Pharmaceutical forms of diazabicyclooctane derivatives and manufacturing method thereof |
| CA3076959A1 (en) | 2017-09-27 | 2019-04-04 | Fedora Pharmaceuticals Inc. | Crystalline forms of diazabicyclooctane derivatives and production process thereof |
| JP6375463B1 (ja) * | 2018-02-28 | 2018-08-15 | 日本曹達株式会社 | ビス（フルオロスルホニル）アミドアルカリ金属塩粉末の製造方法 |
| CN110314163A (zh) * | 2018-03-30 | 2019-10-11 | 杭州森泽医药科技有限公司 | 一种拉氧头孢钠药物组合物及应用 |
| JP2022094481A (ja) * | 2020-12-15 | 2022-06-27 | 大阪瓦斯株式会社 | ヒドロキシアルカン酸結晶の製造方法及びヒドロキシアルカン酸の結晶多形体 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JPS6019759B2 (ja) | 1977-11-24 | 1985-05-17 | イ−ライ・リリ−・アンド・カンパニ− | 非経口投予用１１１１５１５２１３９１９９東京都中央区京橋２丁目３番１３号 |
| GB1589317A (en) * | 1977-11-24 | 1981-05-13 | Lilly Co Eli | Freeze drying cephalothin sodium |
| JPS6019759A (ja) | 1983-07-15 | 1985-01-31 | Nippon Soda Co Ltd | ホルムアミドオキシム誘導体その製造方法及び農園芸用殺菌剤 |
| JPS60255723A (ja) | 1984-05-31 | 1985-12-17 | Ono Pharmaceut Co Ltd | メシル酸ガベキサートの結晶性凍結乾燥製剤及びその製造方法 |
| JPH07117533B2 (ja) | 1985-08-28 | 1995-12-18 | 株式会社生体科学研究所 | トランスフエリンおよびその用途 |
| PL157979B1 (pl) | 1989-02-14 | 1992-07-31 | Sprezyna z dwoma stanami równowagi trwalej PL PL | |
| US20030220521A1 (en) | 1989-07-27 | 2003-11-27 | G.D. Searle & Co. | Renal-selective prodrugs for control of renal sympathetic nerve activity in the treatment of hypertension |
| TW264475B (de) | 1991-09-20 | 1995-12-01 | Takeda Pharm Industry Co Ltd | |
| JP2843444B2 (ja) | 1994-05-02 | 1999-01-06 | 塩野義製薬株式会社 | ピロリジルチオカルバペネム誘導体の結晶，該結晶を含む凍結乾燥製剤，およびその製造方法 |
| AU700545B2 (en) * | 1994-05-02 | 1999-01-07 | Shionogi & Co., Ltd. | Crystal of pyrrolidylthiocarbapenem derivative, lyophilized preparation containing said crystal, and process for producing the same |
| DE19531874C1 (de) | 1995-08-30 | 1996-10-02 | Daimler Benz Ag | Seitenwandbaugruppe für eine Kraftfahrzeugkarosserie |
| TWI233805B (en) * | 1999-07-01 | 2005-06-11 | Fujisawa Pharmaceutical Co | Stabilized pharmaceutical composition in lyophilized form as antifungal agent |
| FR2812635B1 (fr) | 2000-08-01 | 2002-10-11 | Aventis Pharma Sa | Nouveaux composes heterocycliques, preparation et utilisation comme medicaments notamment comme anti- bacteriens |
| FR2825705B1 (fr) | 2001-06-08 | 2005-05-20 | Aventis Pharma Sa | Nouveaux composes heterocycliques, leur preparation et leur utilisation comme medicaments, notamment comme anti-bacteriens |
| FR2835186B1 (fr) | 2002-01-28 | 2006-10-20 | Aventis Pharma Sa | Nouveaux composes heterocycliques, actifs comme inhibiteurs de beta-lactamases |
| FR2921060B1 (fr) | 2007-09-14 | 2012-06-15 | Novexel | Nouveau procede de preparation d'une piperidine disubsituee et nouveaux intermediaires |
| CA2712783C (en) | 2008-01-18 | 2013-03-19 | Timothy A. Blizzard | Beta-lactamase inhibitors |
| FR2930553B1 (fr) | 2008-04-29 | 2010-05-21 | Novexel | Composes azabicycliques, leur preparation et leur utilisation comme medicaments, notamment inhibiteurs de beta-lactamases |
| FR2936798B1 (fr) | 2008-10-03 | 2012-09-28 | Novexel | Nouveaux composes heterocycliques azotes, leur preparation et leur utilisation comme medicaments antibacteriens. |
| US20120053350A1 (en) | 2009-04-30 | 2012-03-01 | Ian Mangion | Preparation of alkyl esters of n-protected oxo-azacycloalkylcarboxylic acids |
| FR2951171A1 (fr) | 2009-10-09 | 2011-04-15 | Novexel | Nouveau sel de sodium d'un compose azabicyclique sous forme enantiomere cristallisee et nouvelles formes polymorphes et pseudopolymorphes ainsi que leur preparation |
| US8772490B2 (en) | 2010-12-22 | 2014-07-08 | Meiji Seika Pharma Co., Ltd. | Optically active diazabicyclooctane derivatives and process for preparing the same |
| AU2011346224B2 (en) | 2010-12-22 | 2017-04-06 | Meiji Seika Pharma Co., Ltd. | Optically-active diazabicyclooctane derivative and method for manufacturing same |
| CN103649051B (zh) | 2011-06-17 | 2016-04-13 | 阿斯利康(瑞典)有限公司 | 制备包括反-7-氧代-6-(磺基氧基)-1,6-二氮杂二环[3,2,1]辛烷-2-甲酰胺的杂环化合物及其盐的方法 |
| MX348974B (es) | 2011-08-27 | 2017-07-04 | Wockhardt Ltd | Derivados 1,6 - diazabiciclo [3,2,1] octan-7-ona y su uso en el tratamiento de infecciones bacterianas. |
| BR112013032974A2 (pt) | 2011-08-30 | 2016-09-06 | Wockhardt Ltd | "derivados de 1,6-diazabiciclo [3,2,1]-octan-7-ona, seus usos, e composições farmacêuticas". |
| CN103781787B (zh) | 2011-09-13 | 2015-09-23 | 沃克哈特有限公司 | 含氮化合物及其用途 |
| US8796257B2 (en) | 2011-12-02 | 2014-08-05 | Naeja Pharmaceutical Inc. | Bicyclic compounds and their use as antibacterial agents and β-lactamase inhibitors |
| US9505761B2 (en) | 2011-12-02 | 2016-11-29 | Fedora Pharmaceuticals Inc. | Bicyclic compounds and their use as antibacterial agents and beta-lactamase inhibitors |
| SG10201605368UA (en) * | 2012-05-30 | 2016-08-30 | Meiji Seika Pharma Co Ltd | NOVEL β-LACTAMASE INHIBITOR AND PROCESS FOR PREPARING THE SAME |
| KR102239725B1 (ko) | 2013-09-24 | 2021-04-12 | 메이지 세이카 파루마 가부시키가이샤 | 디아자비시클로옥탄 유도체의 제조법과 그의 중간체 |
| JP6617029B2 (ja) * | 2013-10-08 | 2019-12-04 | Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 | ジアザビシクロオクタン誘導体の結晶とその製造法 |
| AU2015355970B2 (en) | 2014-12-05 | 2020-05-21 | Meiji Seika Pharma Co., Ltd. | Method for producing crystals of diazabicyclooctane derivative and stable lyophilized preparation |
-
2015
- 2015-12-04 AU AU2015355970A patent/AU2015355970B2/en active Active
- 2015-12-04 WO PCT/JP2015/084094 patent/WO2016088863A1/ja active Application Filing
- 2015-12-04 MY MYPI2017702007A patent/MY190283A/en unknown
- 2015-12-04 ES ES15866317T patent/ES2821826T3/es active Active
- 2015-12-04 KR KR1020177018148A patent/KR102555657B1/ko active IP Right Grant
- 2015-12-04 CN CN201580065691.6A patent/CN107001366B/zh active Active
- 2015-12-04 BR BR112017010445A patent/BR112017010445B8/pt active IP Right Grant
- 2015-12-04 EP EP15866317.9A patent/EP3228620B1/de active Active
- 2015-12-04 TW TW104140714A patent/TWI691499B/zh active
- 2015-12-04 SG SG11201704576SA patent/SG11201704576SA/en unknown
- 2015-12-04 CA CA2969192A patent/CA2969192C/en active Active
- 2015-12-04 AR ARP150103970A patent/AR102915A1/es not_active Application Discontinuation
- 2015-12-04 MX MX2017007191A patent/MX2017007191A/es active IP Right Grant
- 2015-12-04 US US15/532,281 patent/US10294224B2/en active Active
- 2015-12-04 JP JP2016562689A patent/JP6779787B2/ja active Active
- 2015-12-04 RU RU2017123112A patent/RU2732129C2/ru active
-
2017
- 2017-06-05 IL IL252691A patent/IL252691B/en active IP Right Grant
- 2017-06-13 ZA ZA2017/04063A patent/ZA201704063B/en unknown
-
2019
- 2019-03-08 US US16/297,550 patent/US11117895B2/en active Active
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Legal Events
| Date | Code | Title | Description |
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| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
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| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B06A | Patent application procedure suspended [chapter 6.1 patent gazette] | ||
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/12/2015, OBSERVADAS AS CONDICOES LEGAIS |
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| B16C | Correction of notification of the grant [chapter 16.3 patent gazette] |
Free format text: REFERENTE A RPI 2769 DE 30/01/2024, QUANTO AO ITEM (73) NOME DO TITULAR. DEVIDO A ERRO MATERIAL DO PROPRIO |